Telenursing in Coronary Artery Disease

NCT ID: NCT07110779

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-10-31

Brief Summary

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The aim of this research is to determine whether follow-up through telehealth consultations can enhance adherence to medication and increase knowledge about heart disease in patients with coronary artery disease (CAD) who have undergone coronary angioplasty. It can include individuals of any sex or gender, aged over 18, and with access to communication devices such as a cell phone, tablet, or internet-enabled computer. The main questions to be answered are:

* Does follow-up of patients with CAD through telenursing consultations improve adherence to the proposed treatment?
* Does the follow-up of patients with CAD, through telenursing consultations, improve knowledge about heart disease? The researchers will compare these patients with others who will be followed up as usual at the hospital to determine which group shows better adherence to drug treatment and greater knowledge about heart disease. The participants will have telenursing consultations at three intervals: one, three, and five months after the initial consultation. After six months from the first interview, both groups will be assessed. They will also be invited to participate in an activity to share their experiences and identify research priorities in the field, with the option to collaborate on future research.

Detailed Description

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In the face of the global digital transformation, the leadership role of nurses is essential for developing digital health skills and implementing innovative strategies. In the context of coronary artery disease (CAD), telenursing has emerged as a crucial care strategy for monitoring patients, managing risk factors, promoting self-care, and enhancing quality of life.

The researchers will examine the prevalence of comorbidities and risk factors for cardiovascular disease (CVD) in the two study groups. They will also compare adherence to the proposed treatment and knowledge about CAD. Finally, they will draw up a protocol for telenursing consultations for patients with CAD undergoing coronary angioplasty. This protocol will be used at the institution.

Conditions

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Coronary Artery Disease Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Telenursing consultation

The intervention consists of telenursing appointments held at three points in time: one, three and five months after the first appointment.

Group Type EXPERIMENTAL

Telenursing consultation

Intervention Type BEHAVIORAL

Telenursing consultations, which will be carried out via telephone calls, video calls, or messaging platforms, will be held between one, three, and five months after the first consultation. The North American Nursing Diagnosis Association (NANDA-I), the Nursing Outcomes Classification (NOC), and the Nursing Interventions Classification (NIC) taxonomies will be used to structure these consultations.

Traditional follow-up

A final face-to-face evaluation will be conducted six months after the angioplasty to assess adherence to treatment and understanding of the coronary artery disease.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telenursing consultation

Telenursing consultations, which will be carried out via telephone calls, video calls, or messaging platforms, will be held between one, three, and five months after the first consultation. The North American Nursing Diagnosis Association (NANDA-I), the Nursing Outcomes Classification (NOC), and the Nursing Interventions Classification (NIC) taxonomies will be used to structure these consultations.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing coronary angioplasty who have access to communication devices (mobile phone, tablet or computer with internet access).

Exclusion Criteria

* Patients with serious comorbidities that prevent remote monitoring, those without access to the necessary technology for remote nursing, and those with a diagnosis that prevents communication.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil

OTHER

Sponsor Role collaborator

Fernanda Maria Alves Lima

OTHER

Sponsor Role lead

Responsible Party

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Fernanda Maria Alves Lima

Collaborating professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Fernanda MA Lima, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Estadual Paulista "Júlio de Mesquita Filho" - Unesp

Locations

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Faculdade de Medicina de Botucatu - UNESP

Botucatu, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Fernanda MA Lima, PhD

Role: CONTACT

+55 14 3880-1301

Marla AG Avila, Professor

Role: CONTACT

+55 14 3880-1707

Facility Contacts

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Fernanda M A Lima, PhD

Role: primary

+55 14 3880-1301

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Related Links

Access external resources that provide additional context or updates about the study.

https://www.who.int/news-room/fact-sheets/detail/noncommunicable-diseases

World Health Organization (WHO). Noncommunicable diseases.

https://www.ncbi.nlm.nih.gov/books/NBK554410/

Risk Factors for Coronary Artery Disease

https://www.cofen.gov.br/resolucao-cofen-no-5642017/

Conselho Federal de Enfermagem - COFEN. Código de Ética dos Profissionais de Enfermagem.

https://www.who.int/docs/default-source/documents/gs4dhdaa2a9f352b0445bafbc79ca799dce4d.pdf

World Health Organization (WHO). Global strategy on digital health 2020-2025.

https://bvsms.saude.gov.br/bvs/publicacoes/estrategia_saude_digital_Brasil.pdf

Brasil. Ministério da Saúde (MS). Estratégia de Saúde Digital para o Brasil 2020-2028.

https://legis.senado.leg.br/norma/36665930/publicacao/36672979

Brasil. Lei n° 14.510, de 27 de dezembro de 2022. Altera a Lei nº 8.080, de 19 de setembro de 1990, para autorizar e disciplinar a prática da telessaúde em todo o território nacional.

https://www.in.gov.br/en/web/dou/-/portaria-gm/ms-n-635-de-22-de-maio-de-2023-484773799

Brasil. Portaria GM/MS n° 635, de 22 de maio de 2023. Institui, define e cria incentivo financeiro federal de implantação, custeio e desempenho para as modalidades de equipes Multiprofissionais na Atenção Primária à Saúde.

https://www.paho.org/ish/images/docs/covid-19-teleconsultas-pt.pdf?ua=1

Organização Pan-Americana de Saúde (OPAS). Organização Mundial da Saúde. Teleconsulta durante uma pandemia.

https://www.cofen.gov.br/resolucao-cofen-no-0634-2020/

Conselho Federal de Enfermagem (COFEN). Resolução n° 634/2020. Autoriza e normatiza a teleconsulta de enfermagem como forma de combate à pandemia provocada pelo novo coronavírus (Sars-Cov-2)

https://www.cofen.gov.br/wp-content/uploads/2022/05/Resolucao-696-2022.pdf

Conselho Federal de Enfermagem (COFEN). Resolução n° 696/2022. Dispõe sobre a atuação da Enfermagem na Saúde Digital, normatizando a Telenfermagem.

https://www.cofen.gov.br/resolucao-cofen-no-736-de-17-de-janeiro-de-2024/

Conselho Federal de Enfermagem (COFEN). Resolução COFEN nº 736/2024. Dispõe sobre a implementação do Processo de Enfermagem em todo contexto socioambiental onde ocorre o cuidado de enfermagem.

https://oxfordbrc.nihr.ac.uk/wp-content/uploads/2017/03/RDS-PPI-Handbook-2014-v8-FINAL-2.pdf

National Institute for Health Research (NIHR). Patient and public involvement in health and social care research: a handbook for researchers.

https://repositorio.ufrn.br/handle/123456789/59058

Ebook - Envolvimento do paciente e do público em pesquisas

https://conselho.saude.gov.br/resolucoes/2012/Reso466.pdf

Conselho Nacional de Saúde (BR). Resolução nº 466, de 12 de dezembro de 2012.

Other Identifiers

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TELENURS_CAD

Identifier Type: -

Identifier Source: org_study_id

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